CHICAGO, May 12 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced its financial results for the first quarter ended March 31, 2009.

The net loss allocable to common shareholders for the three months ended March 31, 2009 was $2.3 million or ($0.06) per share compared to a net loss allocable to common shareholders of $3.6 million or ($0.09) per share for the three months ended March 31, 2008. The decrease in the net loss is due to decreased costs involved in the clinical development of the Company's lead compound, cethromycin.

The company ended the first quarter of 2009 with cash and cash equivalents totaling $0.5 million. Cash used during the quarter was approximately $1.6 million.

"Our efforts in the first quarter were focused on preparing for the June 2nd FDA advisory committee meeting which will review the cethromycin New Drug Application," said Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences. "We look forward to the opportunity to present the FDA panel with a compelling rationale for recommending the approval of cethromycin in the treatment of community acquired pneumonia."

Operating Expense Analysis

Research and development expenses were $0.9 million for the three months ended March 31, 2009 compared to $1.9 million for the three months ended March 31, 2008.

Selling, general and administrative expenses totaled $1.5 million compared to $1.7 million for the first quarter of last year.

First Quarter Achievements

Received notice from the U.S. Food and Drug Administration (FDA) that the agency's Anti-Infective Drugs Advisory Committee (AIDAC) is scheduled to meet on June 2, 2009, and will discuss the New Drug Application (NDA) for cethromycin, a new once-a-day oral antibiotic for the outpatient treatment of adults with mild-to-moderate community acquired pneumonia (CAP);

Notified by the U.S. Department of Defense that it would exercise its option to award the Company $2.0 million under the previously announced contract to further study cethromycin as a potential broad-spectrum medical countermeasure;

Advance negotiations with prospective U.S. and E.U. partners for the commercialization of cethromycin;

Support the regulatory process associated with the FDA's review of the cethromycin NDA and plan for ex-U.S. regulatory filings;

Under the DOD contract, continue studies of cethromycin as a broad spectrum medical countermeasure; and

Continue preparing for commercial launch of cethromycin.

Financial Outlook

To fund ongoing operations in 2009, the Company intends to raise additional capital through commercial partnerships and/or the sale of equity.

Conference Call Details

Advanced Life Sciences will host a conference call and live webcast at 10:00 a.m. Eastern Time on Tuesday, May 12, 2009 to discuss the company's first quarter financial results.

The conference call will be webcast simultaneously over the Internet. Please visit the Investor Relations section of the Advanced Life Sciences corporate website www.advancedlifesciences.com. Alternatively, callers may participate in the conference call by dialing 888.713.4209 (domestic) or 617.213.4863 (international). The passcode for the conference call is 17640677. A replay of the conference call will be available until May 19, 2009. Callers may access the telephone replay by dialing 888-286-8010 (domestic) or 617-801-6888 (international), passcode 53463919. Investors are advised to dial into the call at least ten minutes prior to the call to register. Participants may pre-register for the call at https://www.theconferencingservice.com/prereg/key.process?key=PC4ENFB8V. Pre-registrants will be issued a pin number to use when dialing into the live call which will provide quick access to the conference by bypassing the operator upon connection.

About Cethromycin

Cethromycin has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria associated with respiratory tract infections, and, again in in vitro tests, it appears to be effective against penicillin- and macrolide-resistant bacteria. Cethromycin has a mechanism of action that may slow the onset of future bacterial resistance. In addition to its utility in CAP, cethromycin is also being investigated for the prophylactic treatment of inhalation anthrax post-exposure. The FDA has designated cethromycin as an orphan drug for the prophylactic treatment of inhalation anthrax post exposure, but the drug is not yet approved for this or any other indication.

About Advanced Life Sciences

Advanced Life Sciences is a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and respiratory diseases. The Company's lead candidate, cethromycin, is a novel once-a-day oral antibiotic in late-stage development for the treatment of respiratory tract infections including CAP. For more information, please visit us on the web at www.advancedlifesciences.com.

Forward-Looking Statements

Any statements contained in this press release that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements represent our management's judgment regarding future events. The Company does not undertake any obligations to update any forward-looking statements whether as a result of new information, future events or otherwise. Our actual results could differ materially from those discussed herein due to several factors including the success and timing of our clinical trials, the adequacy of our clinical results, the timing and terms of any commercial partnership, and our ability to obtain and maintain regulatory approval and labeling of our product candidates; our plans to develop and commercialize our product candidates; the loss of key scientific or management personnel; the size and growth of potential markets for our product candidates and our ability to serve those markets; regulatory developments in the U.S. and foreign countries; the rate and degree of market acceptance of any future products; the accuracy of our estimates regarding expenses, future revenues and capital requirements; our ability to obtain financing on terms acceptable to us; our ability to obtain and maintain intellectual property protection for our product candidates; the successful development of our sales and marketing capabilities; the success of competing drugs that become available; and the performance of third party collaborators and manufacturers. These and additional risks and uncertainties are detailed in the Company's filings with the Securities and Exchange Commission.

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